When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”. As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.
Topics: 21 CFR 58.130 (15), ALCOA Checklist, FDA
When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”. As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.
Topics: Research Professionals, 21 CFR 58.130 (15), FDA Auditors, ALCOA Checklist
When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”. As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.
Topics: Good Clinical Practice, Research Professionals, ALCOA, 21 CFR 58.130 (15)
Good Clinical Practice is the cornerstone for conducting clinical studies. However, as clinical research professionals we should strive to take “good” to “great”. This requires having historical perspective and a firm understanding of GCP requirements, but it is equally important to know how to properly document authentic research observations.
Topics: Good Clinical Practice, ALCOA, 21 CFR 58.130 (15)
